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BRAIN VOLUME CHANGE AND DISABILITY IN FINGOLIMOD TRIALS
  1. Richard Nicholas1,
  2. Frederik Barkhof2,
  3. Jeffrey Cohen3,
  4. Ernst-Willhelm Radue4,
  5. Ludwig Kappos5,
  6. Dieter Häring6,
  7. Nikolaos Sfikas6,
  8. Philipp von Rosenstiel6,
  9. Gordon Francis7
  1. 1Charing Cross Hospital, London
  2. 2VU University Medical Center Amsterdam, the Netherlands
  3. 3Cleveland Clinic Neurological Institute, Cleveland, OH, USA
  4. 4Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland
  5. 5University Hospital Basel, Switzerland
  6. 6Novartis Pharma AG, Basel, Switzerland
  7. 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Abstract

Objective Investigate relationships between Brain Volume (BV) loss and clinical and MRI outcomes observed in three phase 3 fingolimod trials.

Method Percentage BV change (PBVC) was measured in the core-phases and extensions of FREEDOMS, FREEDOMS II and TRANSFORMS using ‘Structural Image Evaluation Normalization, of Atrophy’. During the core-phases, correlations were assessed between PBVC and: cumulative Gd+-lesion count (LC); T2-lesion volume change (LVC);new/enlarging T2-LC; T1-hypointense LVC; number of confirmed relapses; EDSS score change; and MSFC score change.

Proportions of patients with 3- or 6-month confirmed disability progression (CDP) and correlations between PBVC and EDSS were determined.

Results In FREEDOMS, FREEDOMS II and TRANSFORMS, PBVC consistently correlated best with cumulative Gd+-LC(p<0.0001), new/enlarging T2-LC (p<0.0001) and number of confirmed relapses (p<0.005). PBVC correlated with EDSS and MSFC in FREEDOMS (p<0.001), and with MSFC in FREEDOMS II (p=0.016). In combined study data PBVC correlation with EDSS strengthened over time (month 48, p=0.0001). Stronger correlation was seen in patients with 3- or 6-month CDP (month 48, p<0.0001).

Conclusion BV loss was greatest in patients who relapsed or who developed new Gd+ or T2-lesions. By reducing BV loss, fingolimod may slow disability progression.

  • EPILEPSY

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